ClinicalTrials.gov
ClinicalTrials.gov Menu

GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00089856
Recruitment Status : Terminated (Based on futility analysis showing <30% chance of meeting primary endpoint.)
First Posted : August 18, 2004
Last Update Posted : November 5, 2008
Sponsor:
Information provided by:
Cell Genesys

Brief Summary:
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve
Study Start Date : July 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
2
Standard of care - chemotherapy
Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
Experimental: 1
Immunotherapy
Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine



Primary Outcome Measures :
  1. Survival [ Time Frame: 0 ]

Secondary Outcome Measures :
  1. Bone pain and bone related events [ Time Frame: 0 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • Detectable metastases
  • Any Gleason score
  • ECOG performance status 0-2

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  • Significant cancer related pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089856


  Show 126 Study Locations
Sponsors and Collaborators
Cell Genesys

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cell Genesys, Inc, Cell Genesys, Inc.
ClinicalTrials.gov Identifier: NCT00089856     History of Changes
Other Study ID Numbers: G-0029
(VITAL-1)
First Posted: August 18, 2004    Key Record Dates
Last Update Posted: November 5, 2008
Last Verified: November 2008

Keywords provided by Cell Genesys:
Prostate
Cancer
Metastatic
Hormone-refractory
GVAX
Chemotherapy
Taxotere
Docetaxel
Prednisone
Vaccine
Allogeneic cells
Advanced Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vaccines
Docetaxel
Prednisone
Hormones
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal